- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01444144
Ankle Fracture Treatment in the Elderly
September 29, 2017 updated by: University of Florida
Ankle Fracture Treatment in the Elderly, at Risk Population
The purpose of this study is to track surgical outcomes and post-operative course in patients 55 years of age or older treated for ankle fractures.
Study Overview
Detailed Description
This study seeks to describe and track surgical outcomes associated with the use of a minimally invasive surgical technique used to treat ankle fractures in at-risk patients 55 years of age or older
Study Type
Observational
Enrollment (Actual)
118
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
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Gainesville, Florida, United States, 32607
- UF&Shands Orthopaedics and Sports Medicine Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
At-risk population, at least 55 years of age at time of surgery receiving treatment for ankle fractures.
Description
Inclusion Criteria:
- at least 55 years of age at time of surgery
- receiving treatment for ankle fractures
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Ankle Fracture
Patients aged 55 years at time of surgery undergoing treatment for ankle fractures.
|
Retrospective records review post-operatively until fracture resolved.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Status of Fracture Union
Time Frame: Post-operatively until documentation of fracture healing, assessed up to seven months following surgery.
|
Retrospective records review tracking ankle fractures post-operatively until fracture heals.
|
Post-operatively until documentation of fracture healing, assessed up to seven months following surgery.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-operative Complications
Time Frame: Post-operatively until documentation that complications resolved, assessed up to seven months following surgery.
|
Retrospective record review tracking complications post-operatively until resolved.
|
Post-operatively until documentation that complications resolved, assessed up to seven months following surgery.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kalia K Sadasivan, M.D., University of Florida Department of Orthopaedics and Rehabilitation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2011
Primary Completion (Actual)
April 3, 2011
Study Completion (Actual)
April 3, 2011
Study Registration Dates
First Submitted
September 26, 2011
First Submitted That Met QC Criteria
September 28, 2011
First Posted (Estimate)
September 30, 2011
Study Record Updates
Last Update Posted (Actual)
October 3, 2017
Last Update Submitted That Met QC Criteria
September 29, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 146-2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.